AVID Medical Recalls Biopsy Kits Due to Sterility Concerns
AVID Medical is recalling 340 biopsy kits because they contain sodium chloride ampules subject to a separate recall for quality and sterility issues.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source explicitly identifies the agency classification as Class I. Per the rubric, if the agency's own classification is FDA Class I, the score must never be below 4.
Plain-English summary
AVID Medical, Inc. is recalling 340 kits of Haylard UNIV IMAGING BIOPSY TRUCUSTOM (Model/Item Number: VARV042-03). The recall is due to potential product quality and sterility issues associated with the sodium chloride ampules included in these kits.
The sodium chloride ampules are subject to a separate recall by Spectra Medical. The affected kits were distributed domestically in Illinois, North Carolina, Virginia, and Wyoming. Specific kit lots include 1668365, 1668366, 1688166, 1692637, and 1696930, while the recalled sodium chloride ampule lots are AB5002 and AB4003.
Healthcare facilities and consumers should stop using these kits immediately and contact AVID Medical, Inc. for instructions on how to return or dispose of the affected products.
The recalled product
- Product
- Haylard UNIV IMAGING BIOPSY TRUCUSTOM; Model/Item Number (Kit): VARV042-03;
- Manufacturer
- AVID Medical, Inc.
- Category
- Medical Device — Biopsy Kits
- Hazard
- Affected units
- 340
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- Model/Item Number (Kit): VARV042-03
- UDI-DI: 10809160490822
- Kit Lots: 1668365
- 1668366
- 1688166
- 1692637
- 1696930
- Recalled Sodium Chloride Ampule Lot: AB5002
- AB4003
Distribution
Related recalls
Same manufacturer · AVID Medical, Inc.
See all →- SevereAVID Medical Recalls Haylard 18G Single Shot Epi Trays Due to Sterility Concerns
FDA (Devices) · 2026-09-23
- SevereAVID Medical Recalls Haylard Continuous Nerve Block Kits
FDA (Devices) · 2026-09-23
- SevereAVID Medical Recalls Haylard Basic Biopsy Trays Due to Sterility Concerns
FDA (Devices) · 2026-09-23
- HighAVID Medical Recalls Halyard IV Start Kits Due to Mold Contamination
FDA (Devices) · 2026-09-23
- HighAVID Medical Recalls Halyard IV Start Kits Due to Seal Defects
FDA (Devices) · 2026-09-16
Same hazard · sterility
See all →- SeverePfizer Recalls Dopamine Hydrochloride Injection Due to Sterility Concerns
FDA (Drugs) · 2026-09-23
- CriticalAmerican Regent Recalls Epinephrine Vials Due to Particulate Matter
FDA (Drugs) · 2026-09-16
- SevereBaxter Recalls Vasopressin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- SevereRegeneron Recalls Libtayo Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-08-26
- SeverePrestige Recalls Clear Eyes Maximum Itchy Eye Relief Due to Sterility Concerns
FDA (Drugs) · 2026-08-19